The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under warnings, malalignment or soft tissue imbalance can place inordinate forces on the components which may cause excessive wear to the patellar or tibial bearing articulating surfaces.Revision surgery may be required to prevent component failure.Inadequate range of motion due to improper selection or positioning of components.Literature: johnson, simon, jones, peter & newman, john h.(2007) the survivorship and results of total knee replacements converted from unicompartmental knee replacements.The knee 14; 154¿157.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint (b)(4).
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